Reported Mar 18, 2020 · Terminated
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin…
The Harvard Drug Group
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Harvard Drug Group · 17177 N Laurel Park Dr Ste 233 · Livonia, MI · 48152-3951
Is this the product you have?
- Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only
- Manufactured byLupin Limited, Pithampur (M.P.) 454775 India
- Distributed by
Major Pharmaceuticals17177 N. Laurel Park DrSuite 233LivoniaMI 48152 USA
- NDC0904-6804-61
- Lot codes and dates
- Lot
- expiry
Lot N00037exp 05/2021
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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